GlaxoSmithKline told to set up charity for thousands of Australians left crippled by X-ray dye

THOUSANDS of Australians left crippled by dye used in X-rays still battling for compensaton in battle likened to James Hardie asbestos fight.

EXCLUSIVE by Sue Dunlevy

News Corp Australia NetworkFebruary 17, 20135:02pm

Maureen McLean, of Wyong on the NSW Central Coast, is one of thousands of Australians who is suffering from a commonly used medical treatment that failed and now is in severe pain. Picture: Liam DriverSource:News Limited

THEY are the forgotten Australians - 60,000 victims of a devastating medical practice that has left them crippled with pain, paralysed and incontinent.

This week they enjoyed a rare ray of light when Federal Parliament said they deserved the help and support of the drug company linked to their suffering.

GlaxoSmithKline (GSK), which for 42 years marketed a dye used in an X-ray procedure connected to their pain, has been told to set up a charitable foundation to help.

However, while the pharmaceutical giant told News Limited it was “considering” the parliamentary report’s recommendations, it has so far not yet committed to providing any assistance.

Medical experts who gave evidence to a parliamentary inquiry have compared the case to the harm caused by tobacco giants and asbestos company James Hardie.

“I sit back and think: cigarettes, mesothelioma - I go through it all. These people have suffered mainly because they were using a dye, Myodil, with no alternative,” Professor Michael Sage, past president of the Royal Australian and New Zealand College of radiologists told the roundtable.

Between 1945 and 1987 tens of thousands of Australians were injected with a dye during an X-ray procedure called a myelogram that at the time was the only way for doctors to see the spine clearly before surgery.

The federal government, state health authorities and doctors sanctioned the use of the chemical even though they knew evidence had emerged in medical journals as early as the 1950s that it was linked to a condition called arachnoiditis that causes burning back, neck and leg pain.

The condition is caused by the inflammation and fusion of the nerves and membranes of the spinal cord and is estimated to have affected around one per cent of patients who had the procedure.

Pain expert Professor Michael Cousins told the parliamentary roundtable victims suffered pain that was burning and “like bolts of electricity” - just moving to the end of the bed can be enough to trigger a paroxysm of pain.

Patients can also experience loss of muscle function, paraplegia, incontinence, unpleasant sensations such as ants walking on the skin or having hot water poured on one’s legs. Many are wheelchair-bound.

Arachnoiditis sufferer Maxwell Scott told the committee he now existed on an electric wheelchair and a bed, transferring from one to the other by means of a slide board.

News Limited first exposed the issue of spinal injections in 2002 and it was raised in federal parliament but the plight of the victims was ignored by the government even though its own medical regulator had evaluated the dye and approved it for general marketing.

Liberal MP Steve Irons pushed for a parliamentary investigation after being approached by a constituent and says it’s time for GSK to “act like a good corporate citizen” and set up a charitable foundation to help the victims.

“I guess if you look at GSK’s website they talk about openness and transparency, but I felt they hadn’t taken responsibility for this and assisted the people who were affected,” he said.

“Where you take no responsibility it smacks of the tobacco industry’s approach to smoking and cancer,” he told News Limited.

The parliamentary roundtable said it had no power to order GSK to pay the victims’ compensation - that was a matter for the courts.

In 2000 GSK faced a class action from 140 Australian victims of the dye, the case was settled out of court and the payouts were confidential .

In 1995, 3,600 UK victims sued GSK but only 426 received an average payout of 16,000 British pounds in an out of court settlement.

In a statement this week GSK said it “had the utmost sympathy for the people who have been, and are, afflicted by arachnoiditis” and believed it had “acted responsibly at all times in relation to the supply of myodil”.

“Arachnoiditis is a complex condition that may be caused by a number of conditions such as spinal infections, surgery and trauma,” the company said.

Many victims can’t get a diagnosis from their doctors, who also fear legal action, and many have their legal options complicated because they had surgery after a myelogram.

There is currently another compensation case underway in Australia but the president of victim support group The Australian Arachnoiditis Sufferers Association NSW, Maureen McLean, says lawyers have warned victims they “could lose their homes if they sue the company unsuccessfully”.

“It just doesn’t seem fair,” she said.

John Hagerman who had a myelogram in the 1970s is greatly disappointed at the parliamentary roundtable’s findings.

”There are thousands of Australians suffering like hell and no direct course to have it properly investigated,” he said.

He wants someone to be made legally responsible for the suffering cause by the dye.

ARACHNOIDITIS: KEY FACTS

1945-87: oil based dyes Myodil and Pantopaque injected for use in spinal x-rays

1956: article in The Lancet links Myodil to persistent pain in head, neck, back and legs

1960s: two articles in journal Radiology link the dye to arachnoiditis and call for it to be removed after x-ray

1969: US officials ask producers of Pantopaque to state on the product it should be removed after x-ray

1970s: UK doctors decide to remove Myodil after the x-ray because of concerns

1971: GSK inserts on its product information advice for Myodil that “occasionally arachnoiditis has been reported”.

1973: GSK changes product information to “emphasise the importance of removing as much Myodil as possible at the time of investigation”

1979: federal Department of Health approves an application to register Pantopaque for general use in Australia

1980s: Pantopaque and Myodil (1987) withdrawn from sale

1995: 3,600 UK patients seek compensation from GSK in relation to Myodil, 426 get a small settlement.

2000: GSK reaches out court settlement with around 140 Australian claims in relation to Myodil

OTHER GSK LEGAL AND REGULATORY BATTLES

2003: GSK drug Seroxat, a common anti-depressant, was banned for use in children aged under 18 in the UK because of concerns it triggered suicides

2010: The licence for GSK’s diabetes drug Avandia was revoked in Europe because of evidence that it could cause heart failure and heart attacks.

2011: GSK settled a US lawsuit over Avandia but continue to fight compensation claims over the drug in Britain. (Avandia is still sold in Australia)

2012: GSK was hit by a $3 billion penalty in the US after revelations it handed out cash, rock concert tickets, pheasant hunting trips to induce doctors to prescribe medicines for unapproved conditions.